However, as high as40%Patients withBCGTreatment shows no response or may recur after treatment. For such“BCGNo Response”High-riskNMIBCPatient, recommended by international guidelinesThe standard treatment is radical cystectomy., which means surgically removing the entire bladder. This is a major, irreversible surgery with significant risks and complications, and the postoperative mortality rate is3%-8%Between.

In addition,NMIBCIt commonly occurs in elderly patients, many of whom are unable or unwilling to undergo this radical surgery due to age, comorbidities, or personal preference. Therefore, there is an urgent clinical need for an effective bladder-sparing, surgery-alternative salvage treatment.

FDAThe approval is mainly based on the keyIIbPeriodSunRISe-1Research Cohort2The positive results. This is a single-arm, open-label clinical trial designed to evaluateINLEXZOMonotherapyBCGNo response, withCISTheNMIBCThe efficacy and safety of patients.

The research results show that, afterINLEXZOAfter treatment,82.4%（95% CI: 72-90) of patients reachedComplete Remission (CR）, that is, no signs of cancer were detected during cystoscopy and biopsy.More encouraging is that this relief has shown strong persistence. Upon reachingCROf the patients, there are51%Patients in complete remissionMaintained for at least12Months。

This data is a breakthrough in the current treatment landscape, offering a highly effective and organ-preserving alternative for a large number of patients who previously had no choice but to undergo surgery.

In terms of safety,INLEXZOThe safety profile is favorable. The most common adverse reactions (incidence rate≥15%) Mainly focused on local and laboratory indicators, such as frequent urination, urinary tract infections, difficulty in urination, urgency, hematuria, bladder irritation, and transient abnormalities in laboratory indicators (such as decreased hemoglobin, elevated creatinine, etc.). Most of these reactions are related to the local action of the drug in the bladder, and are generally controllable. No new significant safety signals have been found.

InBCGNo ResponseNMIBCTreatment Field,INLEXZOThe approval has given it a unique competitive position.

Traditional Treatment，BCGAfter perfusion failure, the standard option is radical cystectomy. The efficacy of intravesical instillation with other chemotherapeutic drugs (such as gemcitabine, docetaxel) is limited and not durable.

ImmunotherapyAspect，Merck's Pembrolizumab (Keytruda）ObtainedFDAApproved for the same population, with a complete remission rate (CRRate) approximately in41%Left and right, but the median duration of relief is approximately13Months.INLEXZOInCRShow significant advantages in rate (82.4% vs ~41%）。

Gene TherapyAspect，Ferring PharmaceuticalsAdenovirus Vector Gene TherapyAdstiladrin^®（nadofaragene firadenovec-vncg）Has also been approved, with itsCRRate of51%, with effects lasting approximately half a year.INLEXZOShowed advantages in response rate and durability.

Therefore,INLEXZOWith its excellent efficacy data and innovative drug delivery methods, it has established strong competitiveness in the treatment field.